Bionovo Comments on Recent Hormone Therapy (HT) Risk Disclosures

Bionovo Seeks to Develop HT Alternatives for Hot Flashes and Other Symptoms of Menopause

Oct 25, 2010, 08:00 ET from Bionovo, Inc.

EMERYVILLE, Calif., Oct. 25 /PRNewswire/ -- Bionovo Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer derived from botanicals, today commented on the Journal of the American Medical Association (JAMA) publication on an eleven year trial studying the risks associated with the use of Hormone Therapy (HT) for the treatment of menopausal symptoms such as hot flashes.

"These study results join a long list of known HT risks, which we have summarized in an attached exhibit. Currently, all HT and other estrogen products prescribed for the treatment of hot flashes come with seven 'black box' warnings on the label, of potentially life-threatening side effects. Related to this, it has been reported that there are pending more than 5,000 lawsuits for damages due to HT use," said Tom Chesterman, SVP and CFO of Bionovo.

"There are no safe, effective treatments for the 40 million menopausal women suffering from hot flashes in the United States today. Bionovo's drugs may provide new, safe and effective treatments for the alleviation of hot flashes and other menopausal symptoms. We have published recently on new paradigms for ethical drug development that have the potential to replace hormone therapy. Our drug candidate, Menerba, for the treatment of menopausal hot flashes, is about to enter advanced clinical trials," continued Mr. Chesterman. "We hope that we will be able to demonstrate that Menerba is a safe and effective treatment for hot flashes, while not increasing the risk of breast cancer. In fact, if the animal model data are confirmed eventually in human trials, we may see that Menerba has the potential to prevent breast cancer."

About Menerba

Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a Phase 2 trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.

About Bionovo, Inc.

Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources, which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes it has discovered new classes of drug candidates within its rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and its stock is traded on the NASDAQ Capital Market under the symbol "BNVI." For more information about Bionovo and its programs, visit http://www.bionovo.com.

Forward Looking Statements

This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.

Risks Associated With Hormone Therapy

Outcome

Relative Risk

Publication

Coronary heart disease

1.29 (E+P)*

Writing Group for the WHI Investigators. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results from the WHI Randomized Controlled Trials. JAMA. 2002; 288 (3): 321-333.

Coronary heart disease Death

1.18 (E+P)

WHI Paper

Nonfatal myocardial infarction

1.32 (E+P)

WHI Paper

Stroke

1.41 (E+P)

WHI Paper

Venous thromboembolic disease

2.11 (E+P)

WHI Paper

Cancer

1.03 (E+P)

WHI Paper

Invasive breast cancer

1.26 (E+P)

WHI Paper

Ovarian cancer

1.58 (E+P)

Anderson GL; Judd HL; et al. Effects of Estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: The WHI randomized Trial. JAMA. 2003 Oct 1; 290 (13): 1739-48.

Endometrial cancer

2.30 (E) 9.50 (E) >10 yr

Grady; Gebretsadik T; Kerlikowski K; et al. Hormone replacement therapy and endometrial cancer risk:ameta- analysis. Obstet Gynecol. 1995 Feb;85(2):304-13

Global index**

1 .15 (E+P)

WHI Paper

Dementia

2.05 (E+P)

Shumaker, S; Legault C; Rapp S; et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the WHI memory study: a randomized controlled trial. JAMA. 2003; 289(20): 2651-2662.

Urinary incontinence (stress)

1.87(E alone)

Hendrix, S; Cochrane, B; Nygaard, I. Effects of Estrogen with and without Progestin on Urinary Incontinence. JAMA. 2005; 293(8): 935-948.

Lung cancer incidence

1.23 (E+P)

Chlebowski, R; Schwartz, AG, Wakelee, H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (WHI trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10; 374 (9697): 1243-51.

NSCLC (non-small lung cancer)

1.28 (E+P)

Chlebowski, R; Schwartz, AG, Wakelee, H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (WHI trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10; 374 (9697): 1243-51.

SCLC (small lung cancer)

1.58 (E)

Chlebowski, R; Anderson, G; Manson, JE.; et all. Lung Cancer Among Postmenopausal Women Treated with Estrogen Alone in the WHI Randomized Trial. J Natl Cancer Inst 2010; 102: 1413-1421

Death from lung cancer

1.71 (E+P)

Chlebowski, R; Schwartz, AG, Wakelee, H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (WHI trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10; 374 (9697): 1243-51.

Death from NSCLC

1.87 (E+P)

Chlebowski, R; Schwartz, AG, Wakelee, H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (WHI trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10; 374 (9697): 1243-51.

Death from SCLC

2.11(E)

Chlebowski, R; Anderson, G; Manson, JE.; et all. Lung Cancer Among Postmenopausal Women Treated with Estrogen Alone in the WHI Randomized Trial. J Natl Cancer Inst 2010; 102: 1413-1421

Increase in invasive breast cancer

1.25 (E+P)

Chlebowski, R; Anderson G; Gass, M, et al. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA. 2010; 304(15): 1684-1692.

Increase in invasive breast cancer

1.25 (E+P)

Chlebowski, R; Anderson G; Gass, M, et al. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA. 2010; 304(15): 1684-1692.

Increase in deaths of breast cancer

1.96 (E+P)

Chlebowski, R; Anderson G; Gass, M, et al. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA. 2010; 304(15): 1684-1692.

Cholecystitis (gallbladder attack)

2.1 (HRT)

Grodstein F; Colditz GA; Stampfer MJ. Postmenopausal hormone use and cholecystectomy in a large prospective study. Obstet Gynecol. 1994 Jan: 83(1):5-11.

Nephrolithiasis (kidney stones)

1.21 (HRT)

Maalouf N; Sato, A; Welch B; et al. Postmenopausal hormone use and the risk of Nephrolithiasis. Arch Intern Med. 2010; 170(18): 1678-1685

*E+P: Estrogen + Progesterone, E: Estrogen only, HRT: Hormone Replacement Therapy

**Global index: the first event for each participant from among the following types: CHD, stroke, PE, breast cancer, endometrial cancer, colorectal cancer, hip fracture and death due to other causes.

SOURCE Bionovo, Inc.



RELATED LINKS

http://www.bionovo.com